(413 days)
Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.
The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
The ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).
The provided document is a 510(k) premarket notification letter and summary for the ZOLL 731 Series Ventilator. It details the device, its intended use, and the comparisons made to a predicate device to establish substantial equivalence.
However, the request asks for information about acceptance criteria and a study that proves a device meets those criteria, specifically in the context of an AI/algorithm-driven medical device. The document provided does not describe an AI/algorithm-driven device. Instead, it is for a ventilator (a mechanical device with updated software), and the "study" referred to is primarily non-clinical evidence (software verification and validation testing, safety testing per international standards, electrical safety, EMC, and usability testing with no changes to the UI). There is no mention of an algorithm or AI that generates outputs requiring ground truth, expert adjudication, or MRMC studies for evaluation.
Therefore, I cannot fulfill the request with the provided input because the input document does not contain the necessary information about acceptance criteria and studies for an AI/algorithm-driven device.
The document explicitly states:
- "Clinical evidence was not necessary to show substantial equivalence."
- The primary change is a "software revision 5.25, which updates the ventilator alarm logic." This is a rule-based or programmatic change, not an AI/ML model.
- The comparison is based on "Alarm System, Functions and Features, Indications for Use, Intended Use, Labeling, Pulse Oximeter Specifications, Ventilator Specifications." These are typical for traditional medical device updates, not AI.
If the request refers to general device acceptance criteria and testing (not specific to AI/algorithms), then the relevant parts of the document are the "Substantial Equivalence - Non-Clinical Evidence" section, which details the various tests and standards met:
- Software Verification and Validation Testing: This is the primary "study" proving the device meets its software-related acceptance criteria. The document states this testing "ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all its functional requirements and performance specifications."
- Safety Testing per International Standards: Compliance with a long list of international standards (IEC 60601-x, ISO 15223-1, EN 1789, etc.) serves as the acceptance criteria for safety and effectiveness in various aspects. The "Table 1: 731 Series Ventilator Compliance Standards" lists these.
- Usability Testing: The document states "No usability validation is included in this plan. The user interface remains unchanged." This implies that the acceptance criterion for usability was "no change from predicate" and thus no new testing was needed.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested to meet applicable standards listed in Table 1.
However, the request is very specific about AI-related evaluation elements (MRMC, standalone algorithm, ground truth methods, training set, etc.), which are entirely absent from the provided document.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).